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CompletedNCT02600507

ITI-007 Adjunctive to Lithium or Valproate for depression

This study is completed in the United States, in Bulgaria, in Russia, .... It is testing ITI-007 Adjunctive to Lithium or Valproate for depression.

Bipolarity, DepressionDrugFrom 18 Years to 75 Years
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Study ID: NCT02600507. We help you review the study, but cannot decide medical eligibility.
In plain English

Key information made simple

This summary needs review. Please check the official study record and contact the research team for details.

What to expect

Your next step

The official record suggests in-person participation through a clinic, with sites including Clinical Site in Rogers, Clinical Site in Cerritos, and Clinical Site in Costa Mesa. Participation appears to involve guided sessions or support activities with check-ins on how they fit into daily life. The main fit is usually meeting the main study requirements and having a stable enough treatment background for the study, while common reasons not to take part include pregnancy or breastfeeding and other factors that could make participation unsuitable. This is a later-stage study, which usually means a larger group and a closer look at how well the approach holds up.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: March 7, 2016
Recruitment status
Completed
Estimated enrollment
Not clearly listed
Sponsor
Intra-Cellular Therapies, Inc.
Sponsor type
Other organization
Study type
Drug
Intervention type
Medication / drug
Study phase
Not clearly listed
Locations
United States, Bulgaria, Russia, ...
Age range
From 18 Years to 75 Years
Official registry ID
NCT02600507
Official title
Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder
Official source
Official registry link

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Study ID: NCT02600507. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular visits and structured follow-up.

Requires travel, with in-person participation in Bulgaria.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with bipolarity. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study. The phase is not clearly listed in the public registry. Phase is mostly relevant for medication studies and some device studies. For this study, it may be more useful to look at what is required, the duration, visits, and eligibility criteria.

Who might this study be for?

This study may concern people with bipolarity; age range: From 18 Years to 75 Years. The criteria appear fairly specific, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Intra-Cellular Therapies, Inc., which appears to be another type of organization. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The registry indicates that this study is completed. It may still be useful for understanding the research, but you are unlikely to be able to join.

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